Versatex VTX1515X3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521532632), received between May 21, 2021 and Aug 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ABDOMINAL PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22786485 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Adhesion(s); Hernia; Unspecified Tissue Injury

  MAUDE report 15997614 ↗
• InjuryMay 21, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN EPIGASTRIC HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, MESH FREE FLOATING, RECURRENCE, SCARRING, SEROMA, INFECTION, NECROSIS, PAIN, OPEN WOUND, AND FLUID COLLECTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH DISSECTED AWAY FROM THE PERITONEAL LATER/ RESUTURED TO THE FASCIA, REVISION SURGERY, INCISION/DRAINAGE OF SEROMA/FLUID COLLECTION, AND DEBRIDEMENT OF NECROTIC GRANULATED TISSUE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Fluid Discharge; Hernia; Impaired Healing; Inflammation; Necrosis; Pain; Purulent Discharge; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11867268 ↗